This invention relates to a soporific, or sleep-inducing composition, containing lorazepam, for oral or rectal administration.
For many people, especially the ill, fulfilling the vital need for a recuperative sleep is ultimately possible only with medicinal aid. This has been for many decades a spur to the new and further development of still more suitable soporifics. Among these, the benzodiazepine hypnotics are broadly used. Representatives of this group with a long half-life result, after repeated use, in accumulation and morning hangover, while the use of benzodiazepines with a very short half-life leads to sedimentation effects and an increased dependence potential. In this group of hypnotics, lorazepam, with a medium half-life, is an important representative. Lorazepam is the unpatented (generic) name of 7-chlor-5-(2-chlorphenyl)-1,3-dihydro-3-hydroxy-2H-1,4 benzodiazepin-2-on. It is known, however, from many years of use of this substance, that its use as a hypnotic is not without problems, since with the giving of somewhat higher doses there are sometimes relatively strong side effects, such as muscle relaxation, ataxia and sedative after-effects, which may occur in the next few days. These side effects are often seen to be intensified, especially in older patients, even with single doses of 2 to 3 milligrams, so that individual doses of more than 1 mg lorazepam may be problematical as to the risk of side effects. Up to now it has not been possible to strengthen the effect of lorazepam without having to tolerate these side effects.
A need therefore exists for a soporific which is effective and, at the same time, well tolerated. According to experience, this goal cannot be well attained by increasing the dose of lorazepam.